Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Specificity testing on a representative lot met all specifications.Complaint data review by lot and device history record review could not be performed since the suspect medical device lot is unknown.However, review of the prism metrics field data from january - august 2014 indicates that the product is meeting labeling claims for clinical specificity.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
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